50 Participants Needed

AAC Intervention for Intellectual Disability

ED
AC
Overseen ByAlexandria Cook, B.A.
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this mixed methods study aims to develop and pilot test an augmentative and alternative communication (AAC) intervention for toddlers with intellectual and developmental disabilities (IDD) and their families. The main question it aims to answer is: Will this AAC intervention improve caregivers' use of naturalistic AAC intervention strategies, leading to increases in children's communication? The investigators will employ qualitative methods to conduct interviews to determine caregiver and speech-language pathologist preferences regarding an AAC intervention. Findings from these interviews will inform the adaptation of the AAC intervention procedures, service delivery approach, and strategies to increase caregiver's treatment adherence. Next, the researchers will conduct six multiple baseline designs across behaviors (AAC strategies) to develop the AAC intervention and demonstrate preliminary efficacy when delivered to families in-person. Caregiver-child dyads will receive 24 in-person intervention sessions during which the therapist will provide AAC instruction and coaching on using AAC strategies to caregivers. Last, the investigators will pilot test the AAC intervention using a hybrid telehealth model with nine caregiver-child dyads. Caregiver-child dyads will receive 24 intervention sessions, eight sessions provided to families in-person, and 16 sessions provided to families via telehealth. Our long-term goal is to develop a socially valid and effective intervention to improve language outcomes for toddlers with IDD. The researchers propose developing and pilot testing a hybrid telehealth AAC intervention for toddlers with IDD and their families. Researchers employ an implementation science approach, using systematic qualitative methods to identify caregivers' preferences and single-case experimental design methods to assess the feasibility of the AAC intervention. The central hypothesis is that the intervention will improve caregivers' use of naturalistic AAC intervention strategies, leading to increases in children's communication.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Early Augmentative and Alternative Communication (AAC) Intervention for Intellectual Disability?

Research shows that augmentative and alternative communication (AAC) devices can help adolescents with severe intellectual disabilities improve their communication abilities, suggesting potential benefits for similar interventions in younger children with intellectual disabilities.12345

Is AAC intervention safe for humans?

The research does not provide specific safety data for AAC interventions, but these interventions are generally considered safe as they involve communication methods and technologies to help people with limited speech or language skills.36789

How is the Early AAC Intervention treatment different from other treatments for intellectual disability?

Early AAC Intervention is unique because it uses technology and methods to help people with limited speech or language skills communicate more effectively, which is not typically addressed by other treatments. It is particularly beneficial for individuals who are often overlooked due to having some speech abilities, and it can enhance independence and self-determination.367810

Research Team

ED

Emily D. Quinn, Ph.D.

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for toddlers aged 24-36 months with intellectual and developmental disabilities (IDD) who have severe language delays but can sit up, interact, and use AAC systems. Caregivers must be fluent in English, over 18 years old, and experienced in early intervention. Speech-language pathologists should also speak English fluently, have experience with AAC in children with IDD, and work full or part-time providing language intervention.

Inclusion Criteria

I am the main caregiver for a child aged 2 to 3 years with intellectual and developmental disabilities.
Children who have very limited ability to speak and communicate using words or gestures.
Criterion: Speech-Language Pathologists who work with at least one child who uses AAC.
See 16 more

Exclusion Criteria

My child's seizures are not controlled by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Stable baseline performance is established for parent and child outcomes

3-5 sessions

Intervention Development

Development of AAC intervention through iterative testing cycles with in-person sessions

24 sessions
24 visits (in-person)

Pilot Testing

Pilot test of hybrid telehealth AAC intervention with a combination of in-person and telehealth sessions

24 sessions
8 visits (in-person), 16 visits (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after intervention

3-4 months

Treatment Details

Interventions

  • Early Augmentative and Alternative Communication (AAC) Intervention
Trial OverviewThe study tests an AAC intervention to improve communication in toddlers with IDD using a hybrid telehealth model. It involves interviews to tailor the approach based on caregiver preferences followed by pilot testing both in-person and via telehealth sessions to evaluate its effectiveness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Early Augmentative and Alternative Communication (AAC) InterventionExperimental Treatment1 Intervention
After a period of stable baseline performance (3 to 5 sessions) on parent and child outcomes, the interventionist will apply the early AAC intervention.

Early Augmentative and Alternative Communication (AAC) Intervention is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Augmentative and Alternative Communication for:
  • Intellectual and Developmental Disabilities (IDD)
  • Autism Spectrum Disorder (ASD)
  • Cerebral Palsy
  • Other developmental disabilities
🇪🇺
Approved in European Union as Augmentative and Alternative Communication for:
  • Intellectual and Developmental Disabilities (IDD)
  • Autism Spectrum Disorder (ASD)
  • Cerebral Palsy
  • Other developmental disabilities
🇨🇦
Approved in Canada as Augmentative and Alternative Communication for:
  • Intellectual and Developmental Disabilities (IDD)
  • Autism Spectrum Disorder (ASD)
  • Cerebral Palsy
  • Other developmental disabilities

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Florida State University

Collaborator

Trials
234
Recruited
41,100+

Findings from Research

This longitudinal qualitative study involving seven participants over two years provides new insights into how individuals with communication disabilities experience and adapt to augmentative and alternative communication (AAC) devices, highlighting the dynamic nature of their expectations and identity changes over time.
The research emphasizes the importance of contextual and temporal factors in shaping outcomes from AAC, suggesting that clinicians can better support users by understanding these influences and engaging in conversations that address broader communication needs beyond just message delivery.
Using longitudinal qualitative research to explore the experience of receiving and using augmentative and alternative communication.Broomfield, K., Judge, S., Sage, K., et al.[2023]
The forum discusses strategies for starting a clinical service aimed at improving communication between patients and healthcare providers, which is crucial for effective treatment.
A large-scale clinical trial demonstrated the implementation of augmentative and alternative communication (AAC) tools in an acute-care setting, highlighting their potential to enhance patient-provider interactions.
Forum on Augmentative and Alternative Communication in Acute Care.Hurtig, RR.[2021]
Speech-language pathologists (SLPs) recognize the importance of Augmentative and Alternative Communication (AAC) for children with severe/profound intellectual and multiple disabilities (S/PIMD), but they find its implementation complex and challenging, often relying on their individual clinical experiences for decision-making.
The preferences and involvement of the child's social network significantly influence SLPs' choices regarding AAC methods, sometimes even more than the child's own abilities, highlighting the need for family-oriented research in AAC interventions.
Augmentative and alternative communication with children with severe/profound intellectual and multiple disabilities: speech language pathologists' clinical practices and reasoning.Rensfeld Flink, A., Thunberg, G., Nyman, A., et al.[2022]

References

Using longitudinal qualitative research to explore the experience of receiving and using augmentative and alternative communication. [2023]
Forum on Augmentative and Alternative Communication in Acute Care. [2021]
Augmentative and alternative communication with children with severe/profound intellectual and multiple disabilities: speech language pathologists' clinical practices and reasoning. [2022]
Augmentative and alternative communication in adolescents with severe intellectual disability: a clinical experience. [2011]
Introducing the therapy outcome measure for AAC services in the context of a review of other measures. [2019]
The complexities of AAC intervention research: emerging trends to consider. [2019]
The state of research and practice in augmentative and alternative communication for children with developmental/intellectual disabilities. [2022]
The role of augmentative and alternative communication for children with autism: current status and future trends. [2020]
AAC Interventions for Individuals with Autism Spectrum Disorders: State of the Science and Future Research Directions. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Using a speech-generating device to enhance communicative abilities for an adult with moderate intellectual disability. [2008]